Suxiao Jiuxin Pills in Microvascular Obstruction in Patients With Acute Coronary Syndrome

Microvascular obstruction is the severe complication of percutaneous coronary intervention (PCI) in patients with acute coronary syndrome. Microvascular obstruction after PCI is often association with poor prognosis. Current treatments do not show improvement in prognosis of microvascular obstruction. Suxiao Jiuxin Pills (SXJX) was shown associated with a reduction in MACE, and an improvement of heart function and quality of life in acute coronary syndrome (ACS) patients with early PCI. To evaluate the effectiveness and safety of SXJX in microvascular obstruction after PCI, the investigators designed this study.

Study Overview

• Status: Not yet recruiting
• Conditions: Acute Coronary Syndrome
• Intervention / Treatment: Drug: Suxiao Jiuxin Pills; Drug: The placebo of Suxiao Jiuxin Pills

• Study Type: Interventional
• Enrollment (Anticipated): 198
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Minzhou Zhang, Professor; Phone Number: +86-13924266368; Email: minzhouzhang@gzucm.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Meet the diagnosis of AMI, prepare for PCI reperfusion therapy;
• Between the ages of 18-75;
• Volunteer to participate in this study and have signed an informed consent form;
• Have a correct understanding of the significance of drug research, and have a good compliance with the observation and evaluation.

Exclusion Criteria:

• Not suitable for coronary intervention;
• With unstable hemodynamics;
• Platelet count<100×109;
• Suspected aortic dissection or acute pulmonary embolism;
• With mechanical complications;
• With uncontrolled acute left heart failure and pulmonary edema;
• With known bleeding history, active bleeding, bleeding constitution, or severe hemostatic and coagulation dysfunction;
• Meantain anticoagulants (such as warfarin or new anticoagulants);
• Severe liver and kidney insufficiency (Child-Pugh B and above, Cr>177μmol/L (2mg/dl) or eGFR<45ml/min/1.73m2);
• CTO, stent stenosis, or severe left main disease;
• History of coronary artery bypass graft surgery;
• Other pathophysiological conditions whose expected survival period is less than 1 year;
• Allergic history to Suxiao Jiuxin Pills;
• Pregnant or lactating women;
• Participating in other clinical studies;
• With other diseases that are not suitable for participating in clinical research.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Suxiao Jiuxin Pills; Suxiao Jiuxin Pills prescription (15 pills loading does, maintenance 6 pills each time, three times a day.) for 180 days	Drug: Suxiao Jiuxin Pills; Suxiao Jiuxin Pills consists Rhizoma Ligustici (Chuan xiong) and Borneolum (Bing pian).
Placebo Comparator: The placebo of Suxiao Jiuxin Pills; The placebo of Suxiao Jiuxin Pills prescription (15 pills loading does, maintenance 6 pills each time, three times a day.) for 180 days	Drug: The placebo of Suxiao Jiuxin Pills; The placebo of Suxiao Jiuxin Pills is similar to Suxiao Jiuxin Pills in appearance, smell, and taste.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline myocardial infarct size at 6 months	MI size measure by CMR	3-5 days after PCI and 180±7 days
Change from baseline incidence of microvascular obstruction at 6 months	Incidence of Microvascular obstruction measure by CMR	3-5 days after PCI and 180±7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline incidence of intramyocardial hemorrhagex at 6 months	Incidence of intramyocardial hemorrhagex measure by CMR	3-5 days after PCI and 180±7 days
Change from baseline incidence of area-at-risk at 6 months	Incidence of area-at-risk measure by CMR	3-5 days after PCI and 180±7 days
Change of ST segment in electrocardiogram	Change of ST segment in electrocardiogram	Baseline, immediately after PCI, 5-7 days after PCI, 30±7 days and 180±7 days
Change of CK-MB	CK-MB	Baseline, immediately after PCI, 5-7 days after PCI, and 180±7 days
Change of cTnI	cTnI	Baseline, immediately after PCI, 5-7 days after PCI, and 180±7 days
Change of NT-proBNP	NT-proBNP	Baseline, immediately after PCI, 5-7 days after PCI, and 180±7 days
Change of ejection fraction in echocardiography	Ejection fraction measure by echocardiography	Baseline, 3-5 days after PCI and 180±7 days
Change of 6 Minute Walk Test	6MWT is used to assess aerobic capacity and endurance	3-5 days after PCI, 30±7 days and 180±7 days
Quantitative flow ratio	Index measure by QFR	During the procedure
Incidence of MACCE	Cardiac death, myocardial infarction, stent thrombosis, stroke or transient ischemic attack, urgent revascularization and re-hospitalization for heart failure	Through study completion, an average of 1 year
Incidence of complications of PCI	Cardiac shock, heart failure, mechanical complications and arrhythmia	Up to 1 month
Incidence of bleeding event	BARC Type 3 or 4	Up to 6 months
Incidence of stent restenosis	stent restenosis measure by CMR	180±7 days
Incidence of death event	Any death	Through study completion, an average of 1 year
Change of Seattle Angina Questionnaire (SAQ)	Seattle Angina Questionnaire (SAQ), the scale has 19 questions, value of each question is from 1 to 6, higher scores mean a better outcome.	baseline, 3-5 days after PCI, 30±7 days, 90±7 days and 180±7 days

Collaborators and Investigators

• Sponsor: Guangzhou University of Traditional Chinese Medicine

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2021
• Primary Completion (Anticipated): September 30, 2023
• Study Completion (Anticipated): September 30, 2023

Study Registration Dates

• First Submitted: February 25, 2021
• First Submitted That Met QC Criteria: March 22, 2021
• First Posted (Actual): March 24, 2021

Study Record Updates

• Last Update Posted (Actual): March 24, 2021
• Last Update Submitted That Met QC Criteria: March 22, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Percutaneous coronary intervention; Acute Coronary Syndrome; Microvascular obstruction; Suxiao Jiuxin Pills
• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Disease; Syndrome; Acute Coronary Syndrome
• Other Study ID Numbers: 2020KT1715

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No